Tag Archive: Pharmacetical Industry

Dec 18 2013

The Drugging of America

The United States and New Zealand are currently the only countries in the world where the pharmaceutical industry is allowed to market and advertise prescription drugs. Direct to consumer advertising is one of two industry practices that have some under fire recently. The other is paying doctors to promote drugs.

One of the biggest market for drugs have been parents concerned about their children’s success in school. Attention Deficit Hyperactivity Disorder (ADHD) is now “the second most frequent long-term diagnosis made in children, narrowly trailing asthma, according to a New York Times analysis of C.D.C. data.”

The Selling of Attention Deficit Disorder

By Alan Schwarz, New York Times

The Number of Diagnoses Soared Amid a 20-Year Drug Marketing Campaign

After more than 50 years leading the fight to legitimize attention deficit hyperactivity disorder, Keith Conners could be celebrating.

Severely hyperactive and impulsive children, once shunned as bad seeds, are now recognized as having a real neurological problem. Doctors and parents have largely accepted drugs like Adderall and Concerta to temper the traits of classic A.D.H.D., helping youngsters succeed in school and beyond.

But Dr. Conners did not feel triumphant this fall as he addressed a group of fellow A.D.H.D. specialists in Washington. He noted that recent data from the Centers for Disease Control and Prevention show that the diagnosis had been made in 15 percent of high school-age children, and that the number of children on medication for the disorder had soared to 3.5 million from 600,000 in 1990. He questioned the rising rates of diagnosis and called them “a national disaster of dangerous proportions.”

“The numbers make it look like an epidemic. Well, it’s not. It’s preposterous,” Dr. Conners, a psychologist and professor emeritus at Duke University, said in a subsequent interview. “This is a concoction to justify the giving out of medication at unprecedented and unjustifiable levels.

The rise of A.D.H.D. diagnoses and prescriptions for stimulants over the years coincided with a remarkably successful two-decade campaign by pharmaceutical companies to publicize the syndrome and promote the pills to doctors, educators and parents. With the children’s market booming, the industry is now employing similar marketing techniques as it focuses on adult A.D.H.D., which could become even more profitable. [..]

Like most psychiatric conditions, A.D.H.D. has no definitive test, and most experts in the field agree that its symptoms are open to interpretation by patients, parents and doctors. The American Psychiatric Association, which receives significant financing from drug companies, has gradually loosened the official criteria for the disorder to include common childhood behavior like “makes careless mistakes” or “often has difficulty waiting his or her turn.”

The idea that a pill might ease troubles and tension has proved seductive to worried parents, rushed doctors and others.

The Selling of ADHD: Diagnoses, Prescriptions Soar After 20-Year Marketing Effort by Big Pharma

Taken at face value, the latest figures on attention deficit hyperactivity disorder (ADHD) suggest a growing epidemic in the United States. According to the Centers for Disease Control, 15 percent of high school children are diagnosed with ADHD. The number of those on stimulant medication is at 3.5 million, up from 600,000 two decades ago. ADHD is now the second most common long-term diagnosis in children, narrowly trailing asthma.

But a new report in The New York Times questions whether these staggering figures reflect a medical reality or an over-medicated craze that has earned billions in profits for the pharmaceutical companies involved. Sales for ADHD drugs like Adderall and Concerta topped $9 billion in the United States last year, a more than 500 percent jump from a decade before. The radical spike in diagnoses has coincided with a 20-year marketing effort to promote stimulant prescriptions for children struggling in school, as well as for adults seeking to take control of their lives. The marketing effort has relied on studies and testimonials from a select group of doctors who have received massive speaking fees and funding grants from major pharmaceutical companies.

We are joined by four guests: Alan Schwarz, an award-winning reporter who wrote the New York Times piece, “The Selling of Attention Deficit Disorder”; Jamison Monroe, a former teenage Adderall addict who now runs Newport Academy, a treatment center for teens suffering from substance abuse and mental health issues; Dr. Gabor Maté, a physician and best-selling author of four books, including “Scattered: How Attention Deficit Disorder Originates and What You Can Do About It”; and John Edwards, the father of a college student who committed suicide after he was prescribed Adderall and antidepressant medications at the Harvard University Health Services clinic.

One drug company, GlaxoSmithKline, a British owned company, has decided to stop paying doctors to promote their prescription drugs:

Andrew Witty, Glaxo’s chief executive, said in a telephone interview Monday that its proposed changes were unrelated to the investigation in China, and were part of a yearslong effort “to try and make sure we stay in step with how the world is changing,” he said. “We keep asking ourselves, are there different ways, more effective ways of operating than perhaps the ways we as an industry have been operating over the last 30, 40 years?”

For decades, pharmaceutical companies have paid doctors to speak on their behalf at conferences and other meetings of medical professionals, on the assumption that the doctors are most likely to value the advice of trusted peers.

But the practice has also been criticized by those who question whether it unduly influences the information doctors give each other and can lead them to prescribe drugs inappropriately to patients. All such payments by pharmaceutical companies are to be made public next year under requirements of the Obama administration’s health care law.

Under the plan, which Glaxo said would be completed worldwide by 2016, the company will no longer pay health care professionals to speak on its behalf about its products or the diseases they treat “to audiences who can prescribe or influence prescribing,” it said in a statement. It will also stop providing financial support directly to doctors to attend medical conferences, a practice that is prohibited in the United States through an industry-imposed ethics code but that still occurs in other countries. In China, the authorities have said Glaxo compensated doctors for travel to conferences and lectures that never took place.

Mr. Witty declined to comment on the investigation because he said it was still underway.

Sep 28 2013

US Demands India Block Production Of Low-Cost Generic Drugs

One of the biggest drivers of health care costs to the patient is medication. Pharmaceutical companies who hold the patents often make minor changes in the drug to gain a new patent and applying for a new patent on essentially the same drug. This is called “evergreening.” A paper in PLOS examined the economic impact of this practice:

The researchers identified prescriptions of eight follow-on drugs issued by hospital and community pharmacists in Geneva between 2000 and 2008. To analyze the impact of evergreening strategies on healthcare spending, they calculated the market share score (an indicator of market competitiveness) for all prescriptions of the originally patented (brand) drug, the follow-on drug, and generic versions of the drug. The researchers then used hospital and community databases to analyze the costs of replacing brand and/or follow-on drugs with a corresponding generic drug (when available) under three scenarios (1) replacing all brand drug prescriptions, (2) replacing all follow-on drug prescriptions, and (3) replacing both follow-on and brand prescriptions. [..]

Using these methods, the researchers found that over the study period, the number of patients receiving either a brand or follow-on drug increased from 56,686 patients in 2001 to 131,193 patients in 2008. The total cost for all studied drugs was €171.5 million, of which €103.2 million was for brand drugs, €41.1 million was for follow-on drugs, and €27.2 million was for generic drugs. Based on scenario 1 (all brand drugs being replaced by generics) and scenario 2 (all follow-on drugs being replaced by generics), over the study period, the healthcare system could have saved €15.9 million and €14.4 million in extra costs, respectively. The researchers also found some evidence that hospital prescribing patterns (through a restrictive drug formulary [RDF]) influenced prescribing in the community: over the study period, the influence of hospital prescription patterns on the community resulted in an extra cost of €503,600 (mainly attributable to two drugs, esomeprazole and escitalopram). However, this influence also resulted in some savings because of a generic drug listed in the hospital formulary: use of the generic version of the drug cetirizine resulted in savings of €7,700.

(emphasis mine).

In a post at his blog, law professor Jonathan Turley explains how President Barack Obama has yielded to the pressures of the pharmaceutical industry and pushed to block access the inexpensive generic drugs, demanding India, one of the world’s largest suppliers of generic drugs, block production of the low cost medications:

Millions of Americans struggle on a daily basis to afford medicine in the United States which is the highest in the world. Many seek affordable drugs by driving to Canada or seeking medicine (as well as medical care) in India. Yet, one of the first things that President Obama did in the new health care law was to cave to a demand by the powerful pharmaceutical lobby to drop provisions guaranteeing cheaper medicine. The lobby then got Congress to block two measures to guarantee affordable medicine. With billions at stake, Congress and the White House again yielded to the demands of this industry, which is sapping the life savings away of millions of families. Given this history, many are concerned about a meeting planned between Obama and the Prime Minister of India. Public interest groups object that Obama is threatening retaliation against India in the hopes of blocking one of the major alternatives for families in acquiring affordable medicine. Congress has also again responded to industry demands for pressure in India to change its laws and, as a result, raise the cost of medicine. Doctors Without Borders, a highly respected medical group, has denounced the effort of the Obama Administration as threatening basic health care for its own citizens and those around the world.

From Doctors Without Boarders press release:

On the eve of a meeting between US president Barack Obama and Indian prime minister Manmohan Singh at the White House, the international medical humanitarian organization Doctors Without Borders/Médecins Sans Frontières (MSF) today warned that India faces retaliatory political pressure from the US government and pharmaceutical industry for its efforts to legally limit abusive patenting practices and to increase access to affordable generic medicines.

Pharmaceutical companies are aggressively lobbying congress and the Obama administration in a broad campaign to press India into changing its intellectual property laws. India is a critical producer of affordable medicines, and competition among generic drug manufacturers there has brought down the price of medicines for HIV, TB, and cancer by more than 90 percent. [..]

The pharmaceutical lobby, led by Pfizer, is currently engaged in a concerted effort to pressure India to change its intellectual property laws. In June, 170 members of US congress wrote a letter to President Obama urging him to send a “strong signal” to India’s high-level officials about its intellectual property policies, and numerous congressional hearings have been held in the past year designed in part to criticize India’s robust defense of public health. Several interest groups have been created to lobby the US government about India’s policies and in early September, US congressional trade leaders requested that the US International Trade Commission initiate an official investigation on India’s intellectual property laws. [..]

Earlier this year, Novartis lost a seven-year-battle to claim a patent on the salt form of the cancer drug imatinib, marketed as Gleevec. The Indian Supreme Court ruled that this new formulation did not meet the patentability requirement in Indian patent law, which limits the common pharmaceutical industry practice of “evergreening,” or extending drug patents on existing drugs in order to lengthen monopolies. [..]

These decisions by the Indian judiciary and government are compliant with all existing international law, including those rules outlined in the World Trade Organization Agreement on Trade Related Aspects of Intellectual Property (TRIPS) and the Doha Declaration on TRIPS and Public Health. Both defend access to existing medicines by allowing countries to use legal flexibilities such as patent oppositions and compulsory licenses to overcome intellectual property barriers. Nevertheless, some US pharmaceutical companies are crying foul, and wrongly accusing India’s patent system of not being consistent with TRIPS.

(all emphasis mine)

As Prof. Turley points out, India is forcing down the cost of drugs making life saving drugs available to millions. If Big Pharma is successful the impact will be life threatening to millions around the world.